Your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment must renew its registration between October 1 and December 31, 2020, regardless of when the initial registration was completed.
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FDA REGISTRATION REQUIREMENT
Companies can export or import food products, dietary supplements or dietary ingredients to or from the United States, as long as the facilities that produce, store, or otherwise handle the products, are registered with the Food and Drug Administration (FDA), and prior notice of incoming shipments is provided to the FDA.
Offering an article that is a drug or medical device for import without establishment registration, is illegal. Even when a Premarket Notification 510(k) is not required, it is necessary to meet other requirements.
Domestic and foreign establishments that manufacture, repack, or re-label animal food or drug products are required to register with the FDA.
All drug and medical device manufacturers, repackers or re-labelers are also required to list all of their commercially marketed products.
U.S. Customs and Border Protection (CBP) officers in consultation with FDA inspectors recently seized:
145 unapproved or counterfeit COVID-19 test kits
337 unapproved or counterfeit COVID-19 antibody diagnostic kits
67,000 counterfeit ACCU-CHEK test strips
792 unapproved or counterfeit N95 respirator masks and other face masks
10,000 unapproved KN-95 respirator masks
600 facemasks imprinted with counterfeit trademarked logos representing Nike, Adidas, Fila, the Liverpool and Manchester City football clubs, among others brands
960 doses of Lianhua Qingwen Jianonangcee and Lianhua Qingwen Pian capsules
These products were shipped from manufacturers and distributors in China, Hong Kong, South Korea, Turkey, Saudi Arabia, UAE, Senegal, Ghana, Nigeria, Kenya, Germany, Poland, Spain, Switzerland, the United Kingdom and Mexico.
The exponential growth of e-commerce has provided illicit sellers with an extraordinary opportunity to sell unsafe and unregulated products to U.S. consumers, particularly through fulfillment centers.
ITB HOLDINGS LLC provides FDA REGISTRATION and COMPLIANCE SERVICES to domestic and foreign manufacturers, exporters, warehouses, importers, or distributors of food products, dietary supplements, canned foods, cosmetics, drugs or medical devices.
Most Food Facility Registrations are completed within 72 hours. Same Day Service is also available, when needed and requested.